GALWAY, Ireland, Jan. 23, 2026 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced two major milestones for the Affera™ Sphere-360™ catheter, a first-of-its-kind, all-in-one mapping and single-shot pulsed field ablation (PFA) catheter for treatment of paroxysmal atrial fibrillation (AFib): CE Mark in Europe and the completion of first cases in the Horizon 360 IDE pivotal trial in the United States.

The Sphere-360 catheter was designed in response to physician feedback expressing the need for a simple, differentiated workflow and predictable outcomes using a single catheter that accommodates anatomical variations in pulmonary veins. Seamlessly integrated with the Affera mapping and ablation system, the catheter offers an adjustable configuration lattice design that conforms to the shape of the veins and allows energy delivery without the need to rotate the catheter in each position.